Effect of High Tone Power Therapy on Neurophysiological Measures and Function Outcome in Patients With Diabetic Neuropathy

NCT03888872 | Completed

• 1 other identifier: P.T.REC/012/002261
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the effect of high tone power therapy on neurophysiological measures and function outcome in patients with diabetic neuropathy.

Conditions

Diabetic Neuropathy Peripheral

Outcome Measures

Primary Outcomes (1)

• Measuring Nerve Conduction Velocity

  Neuro pack M1 EP/EMG measuring system MEB-9200/9300

  Up to 30 days

Study Arms (2)

Group I

EXPERIMENTAL

Group I (Study): will consist of 20 patients with diabetic neuropathy and will receive High tone power therapy in addition to selected physical therapy program (Wobble board training, AROM exercises for both UL \& LL, gentle manual stretching exercises for both UL \& LL and graduated gait training). for 10 sessions every other day, each session for 1.45 hours (60 minutes for HiTop and 45 minutes for selected physical therapy program).

Device: High tone power therapy; Other: Selected Physical Therapy Program

Group II

EXPERIMENTAL

Group II (Control): will consist of 20 patients with diabetic neuropathy and will receive selected physical therapy program only same as group I. For 10 sessions every other day, each session for 45 minutes.

Other: Selected Physical Therapy Program

Interventions

High tone power therapy DEVICE

1- High Tone Power Therapy (HiTop 191): (For group I). The high tone power therapy through using a device (HiTop 191; gbo Medizintechnik, Rimbach, Germany). The intensity of the electrical stimulation will be adjusted to a pleasant level that did not produce any pain or discomfort. Duration: 60 min (Each one electrode to both thighs to the knee, each one electrode to both thighs to the groin). Position: lying / setting, Number of sessions: 10, Frequency of sessions: 3 times per week.

Group I

Selected Physical Therapy Program OTHER

Selected physical therapy program: (For both groups). 1. Wobble board training: 2. Active range of motion exercises (AROM): 3. Gentle manual stretching exercises for both UL \& LL: 4. Graduated gait training:

Group I; Group II

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Forty type II referred diabetic neuropathy patients from both genders their ages will be ranged from 40-60 years old.
• All patients with diabetic neuropathy \> 10 years having diabetes (will be examined according to the general and specific neurological evaluation sheet for diabetic neuropathy).
• All patients in the study should be ambulant independently.
• All patients should be medically stable.
• The body mass index (BMI) ranged from 20:30 Kg/m2.
• All patients will approve and sign a consent form.

You may not qualify if:

• Patients \< 10 years having diabetes.
• Patients with musculoskeletal deformities and disorders.
• Patients with psychiatric disorders or seizures.
• Patients with visual and auditory impairment or tremors influencing balance.
• Patients with other neuromuscular disorders.
• Patients with BMI more than 30 kg/m2.
• Patients with foot deformities and ulcers.
• Patients with cognitive impairment using mini-mental state examination (MMSE).
• Patients with lower limb operations.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University

El-Sheikh Zayed City, Giza Governorate, 1133, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer in Neurological Physical Therapy

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 25, 2019
• Study Start: March 12, 2019
• Primary Completion: June 14, 2020
• Study Completion: September 10, 2020
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

EG (1)